Identity
- Trade Name
- Premier EUDAMED
- Device Name
- Powder Free On Line Chlorinated Nitrile Examination Gloves EUDAMED
- Model / Reference
- P2762AF6, Size L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551013870117 EUDAMED
- Basic UDI-DI
- 955101387NBRM3 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Premier by Yty Industry Sdn Bhd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955101387NBRM3 | Class I | Active |
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Manufacturer
- Manufacturer
- Yty Industry Sdn Bhd
- EUDAMED SRN
- MY-MF-000009643
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 16759c03-ad36-4e75-bd5a-5fa71fe26e2d 61 fields · synced Jul 31, 2026
- EUDAMED 16759c03-ad36-4e75-bd5a-5fa71fe26e2d-1 61 fields · synced Jun 9, 2026